510(k) K254078 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
HVT 2.0
| Applicant | Vapotherm, Inc., Exeter NH, US |
| Decision | Substantially Equivalent, Apr 13, 2026 |
| Received | Dec 18, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254078
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.